AccessGUDID - DEVICE: ORIGINAL HANAU (G619800215170)

GUDID

Device Identifier (DI) Information

Brand Name: ORIGINAL HANAU
Version or Model: OH M 60/80 EF
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 80021517
Company Name: JW NORTH AMERICA, INC.

Primary DI Number: G619800215170
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 039280558 *Terms of Use

Device Description: Ultraviolet tanning device

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46387	Ultraviolet tanning device	A mains electricity (AC-powered) lamp or bed/booth with lamps designed to provide radiation in the ultraviolet spectrum for tanning the skin. This device is used for cosmetic purposes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LEJ	Booth, Sun Tan

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 61ec49e0-7b62-48a0-bd1c-1127a1e1e3b8
Public Version Date: November 11, 2024
Public Version Number: 1
DI Record Publish Date: November 01, 2024